Obesity is a condition of epidemic proportions in the United States. Recent government studies have indicated that up to 40% of Americans are obese, and of those, almost 20% are morbidly obese. In and of itself, however, obesity is not the problem. The difficulty with obesity arises with the multiple conditions, including cardiovascular disease, diabetes, and obstructive sleep apnea, that occur with this ubiquitous problem. There have been many attempts to treat obesity, most of which either have serious side effects or are ineffective.
For example, various diets, supplements, and pharmaceuticals have been developed in an attempt to treat obesity. Typically, these types of treatment have not provided any significant benefit. Indeed, some weight loss pharmaceuticals have been associated with many serious life-threatening conditions. To date, there are no commercially available supplements or drugs on the market that have been found to have significant success in weight reduction.
Recognizing this, the medical industry has turned to more extreme measures, the best example of which is the Roux-En-Y gastric bypass. More effective, but also potentially lethal, this major surgery with 1-2% mortality, 6 month recovery period and a price tag of tens of thousands of dollars, is still increasing in its popularity due to the inefficacy of other treatments. Gastric reduction, or simply removing a large segment of the stomach, is similar to gastric bypass in its potentially lethal combinations.
Progress was made, however, with the introduction of intragastric balloons, as described in U.S. Pat. Nos. 4,739,758; 5,234,454; 4,485,805; and 4,899,747. These balloons, designed to be placed surgically or endoscopically, are constructed of silicone and inflated once positioned in the stomach, thereby reducing effective gastric volume. These balloons were found to be effective in increasing the sensation of fullness in the patient and reducing weight by reducing intake.
Unfortunately, these intragastric balloons still required an invasive procedure and also generated ulcers and other complications due to having the inflexible silicone surface in contact with the stomach wall in the same orientation for months. Also, these devices require further invasive surgery or endoscopic procedures to reduce or increase the balloon volume in the common event that the balloon was filled too much or too little.
A further advancement was proposed by Ratjen in German Patent No. NDN-050003290517 in which a compressed cellulose derivative was utilized. This compressed cellulose derivative was coated with gelatin and was designed to be expanded once ingested into the stomach. The difficulty with this derivation is that cellulose is broken down at roughly equivalent rates in the stomach and small bowel. Thus, any partially digested masses of cellulose that have been passed from the stomach will remain intact in the intestine and cause a possible small bowel obstruction. This risk outweighs the possible benefit, in many cases making the therapy undesirable.
A similar difficulty is likely to be associated with the therapy described in U.S. Pat. Nos. 5,750,585 and 6,271,278. The polymers described therein do not exhibit differential degradation rates in the stomach and the intestine, thereby placing patients at risk for a small bowel obstruction. Therefore, there is a need in the industry to develop more methods and devices, especially noninvasive methods and devices useful for weight loss and/or weight management.